Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.
This Study is a multicenter, single-arm, Phase Ib clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of JYB1904 injection in adolescent participants aged 12-17 years
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904 Injection Group | Experimental | 300 mg JYB1904 injection administered subcutaneously(SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1904 | Drug | Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results | Through study completion, an average of 28 weeks |
| Pharmacokinetic (PK) profile of JYB1904 injection | Maximum Concentration(Cmax) | Through study completion, an average of 28 weeks |
| Pharmacokinetic (PK) profile of JYB1904 injection | Time to Reach Cmax(Tmax) | Through study completion, an average of 28 weeks |
| Pharmacokinetic (PK) profile of JYB1904 injection | Area Under the concentration-time Curve from time zero to the last accurately quantifiable time point(AUC0-t) | Through study completion, an average of 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Other PK Parameters | Terminal Phase Half-life( t1/2) | Through study completion, an average of 28 weeks |
| Other PK Parameters | Area Under the concentration-time Curve from time zero to infinity(AUC0-inf) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xu | Contact | 021-58306003 | xujing2@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Liming Wu | First People's Hospital of Hangzhou | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through study completion, an average of 28 weeks |
| Pharmacodynamic (PD) profile of JYB1904 injection | Changes in serum level of total and free IgE | Through study completion, an average of 28 weeks |
| Immunogenicity of JYB1904 injection | Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab), ADA onset time, duration, and titer | Through study completion, an average of 28 weeks |